Food and Drug Administration--Recalls

• Actavis Recalls Certain Fentanyl Patches in the US as Precaution (Feb. 17) (Mon, 18 Feb 2008 09:50:00 GMT) The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.
• Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled" Because of Possible Health Risk (Feb. 15) (Fri, 15 Feb 2008 22:12:00 GMT) The product comes in a .50 pound clear plastic package with a product SKU #170 at the top and a "packed on" date of December 28. This product was sold from circa December 15, 2007 through January 28, 2008.
• Rocky Mountain Popcorn Company Issues Recall of Low Fat Caramel Popcorn (in the green bag) 9 oz. (Feb. 11) (Fri, 15 Feb 2008 21:42:00 GMT) Rocky Mountain Popcorn Company, Centennial, CO is voluntarily initiating a nationwide recall of 1,603 bags of Low Fat Caramel 9 oz. Popcorn (in the green bag). This recall is on the Low Fat variety only. An ingredient in this product has been found to contain a trace amount of tree nuts, which potentially could cause an allergic reaction to any person with a tree nut allergy.
• Dreyer's Issues Voluntary Recall of Slow Churned Light Caramel Delight and Butter Pecan Ice Cream Flavors for Undeclared Pecans (Jan. 22) (Fri, 15 Feb 2008 21:12:00 GMT) The potentially affected cartons are the 1.75-quart size of Dreyer's Slow Churned Light Caramel Delight and Slow Churned Light Butter Pecan ice cream. The sides of the Slow Churned Light cartons identify the flavor as Caramel Delight, but the carton lids identify it as Butter Pecan. The actual flavor of the ice cream may be Butter Pecan erroneously packaged in Caramel Delightcartons, so Dreyer's is recalling the ice cream to avoid any confusion among consumers who may be allergic to pecans.
• PriCara Recalls 25 mcg/hr DURAGESIC (fentanyl transdermal system) CII Pain Patches (Feb. 12) (Fri, 15 Feb 2008 18:02:00 GMT) PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
• Sherwood Brands Announces Nationwide Recall of Pokemon Branded Valentine Cards and Pops Because They May Contain Metal Fragments (Feb. 14) (Fri, 15 Feb 2008 18:02:00 GMT) Sherwood Brands LLC is voluntarily recalling approximately 400,000 packages of Pokemon branded "Valentine Cards and Pops" (Item# 073964209109 and Item# 073964289804), because of reports that metal fragments were found in two lollipops purchased in Florida. There are no reports of injury. People who bite into or swallow a metal fragment could possibly be injured.
• Summit Import Corporation Issues Allergy Alert on Undeclared Sulfites in Oriental Mascot Brand Sweetened Sliced Coconut (Feb. 1) (Thu, 14 Feb 2008 17:45:00 GMT) Summit Import Corp. is recalling "Oriental Mascot Brand Sweetened Sliced Coconut" because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites may run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in an uncoded 4 oz plastic container. The recalled "Oriental Mascot Brand Sweetened Sliced Coconut" was distributed in New York State.
• See's Candies, Inc. Issues Allergy Alert on Undeclared Milk in Semi Sweet Chocolate Chips (Feb. 12) (Wed, 13 Feb 2008 11:52:00 GMT) The product is sold in a black and white See's logo flexible bag. This recall applies to all code dates (30757, 31327, 32067, 33157, and 23397). The product was distributed through See's owned retail shops in California, Arizona, Nevada, Oregon, Washington, Utah, Colorado, Idaho, Hawaii, New Mexico, and Illinois. Licensees of See's also sold the product in Nebraska, Iowa, Kansas, Michigan, Texas and internationally in Japan and Hong Kong. See's Mail Order department sold small quantities countrywide.
• Nick and Katie's, Inc. Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Crab Stuffed Mushrooms, Crayfish, Stuffed Portabella Mushroom, Stuffed Bell Pepper, Stuffed Crab, Mediterranean Stuffed Artichoke, Stuffed Italian Artichoke, and Artichoke Balls (Feb. 7) (Tue, 12 Feb 2008 11:14:00 GMT) These products are being recalled because they contain milk, soy, and wheat that was distributed in packaging that did not reveal the presence of milk, soy, and wheat. People who have an allergy or severe sensitivity to milk, soy, or wheat run the risk of a serious or life-threatening allergic reaction if they consume these products.
• Annie's Naturals Issues Voluntary Nationwide Allergy Alert on Undeclared Soy in 8 fl oz. All-Natural Shiitake and Sesame Vinaigrette (Feb. 11) (Tue, 12 Feb 2008 10:57:00 GMT) Annie's Naturals is voluntarily recalling 686 cases of 8 fl oz. bottles of all-natural Shiitake and Sesame Vinaigrette. The product could be mislabeled and may contain soy sauce (contains soy and wheat) and sesame that were not declared on the ingredient statement. People who have an allergy or severe sensitivity to soy run the risk of serious allergic reaction if they consume this product.
• Onion Crock of Michigan recalls Old Fashion Potato, Minestrone soups due to Undeclared Allergens (Wheat and Soy)(Feb. 6) (Tue, 12 Feb 2008 10:48:00 GMT) Old Fashion Potato may be packed in one pound frozen pouches (upc # 643640010772) or in four or eight pound pouches (upc codes # 643640001053) with any Best if used by dates of 7/21/09 or earlier. Minestrone packaged in one pound frozen pouches (upc # 64364001111) or in four or eight pound pouches (upc codes # 643640001138) or with any Best if Used by dates of 7/08/09 or earlier.
• Choyce Products Voluntarily Recalls Yellowfin Tuna Due to Possible Health Risk (Feb. 9) (Sun, 10 Feb 2008 14:51:00 GMT) The frozen Yellowfin tuna was distributed on Oahu and most likely reached consumers in the form of a mixed, previously frozen, seafood product through its customers. Choyce Products received the tuna from a mainland importer who confirmed the tuna was sent from Indonesia.
• Chattem Issues URGENT Voluntary Nationwide Recall of Icy Hot Heat Therapy Products (Feb. 8) (Sat, 09 Feb 2008 16:51:00 GMT) Chattem, Inc. announced that it is initiating a voluntary Nationwide recall of its Icy Hot Heat Therapy products, including consumer samples that were included on a limited promotional basis in cartons of its 3 oz. Aspercreme product. Chattem is recalling these products because it has received some consumer reports of first, second and third degree burns as well as skin irritation resulting from consumer use or possible misuse of these products.
• Domega International Ltd., Inc. Issues Alert on Undeclared Sulfites In KORICA Brand Dried Plum (Feb. 4) (Sat, 09 Feb 2008 16:51:00 GMT) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in KORICA BRAND DRIED PLUM which did not declare sulfites on the labels. The consumption of 10 milligrams of sulfites per serving has been reported to illicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.
• New Era Canning Company Announces New Nationwide Recall of Vegetable Products in #10 cans (6 to 7 pound cans) (Feb. 7) (Thu, 07 Feb 2008 19:50:00 GMT) New Era Canning Company of New Era, Michigan is recalling all cans of vegetable products in #10 cans (large cans containing between 6 and 7 pounds) on the list below because they may have been processed under conditions which could have led to contamination by Clostridium botulinum bacterium spores, which can cause life-threatening illness or death.